The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI

Infertility Clinical Trial

— LH  

Official title:

In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108223
• Other study ID #: 4085
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2014
• Last updated: March 2, 2015
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2015
• Source: Sisli Etfal Training & Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.

Description:

1. Aim

-We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.

2. Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 39 Years

Eligibility

Inclusion Criteria:

• Patients aged 23-39

• Body mass index between 18 and 30 kg/m2

• Baseline FSH =12 IU/l, E2 = 80 pg/ml

• The presence of both ovaries and uterine cavity capable of sustaining a pregnancy

• Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation

• Who were having their first or second IVF trial.

Exclusion Criteria:

• Grade III-IV endometriosis

• Clinically significant condition preventing them from undergoing gonadotrophin treatment

• More than two previous assisted cycles

• Who had a single ovary

• Unexplained gynaecological bleeding

• Polycystic ovary or an ovarian cyst of unknown aetiology

• Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity

• Have a chromosomal anomaly.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• fix dose r-FSH (Gonal-f)
recombinant follicle stimulation
• r-LH supplementation
recombinant luteinizing hormone
• r-FSH (Gonal-f)
recombinant follicle stimulation hormone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sisli Etfal Training & Research Hospital	Selcuk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)	Up to 9 month	Yes
Secondary	the Number of Oocytes Retrieved	median number of oocytes retrieved per participant	up to 9 month	Yes
Secondary	Number of Mature Oocyte	median number of mature oocytes retrieved per participant	up to 9 month	Yes
Secondary	Fertilization Rate	fertilization rate used to measure how many oocytes become fertilized by sperm cells	up to 9 month	Yes
Secondary	Implantation Rates	Implantation rate is the percentage of embryos which successfully undergo implantation	up to 9 months	Yes